Abstract

Objective: An ICH-compliant RP-HPLC approach was created and validated in order to measure the concentrations of HCTZ and LIS in bulk and mixed medicinal dosage forms. This procedure was subsequently submitted for certification. Methods: Column, a Phenomenex Luna C18(2) (250 x 4.6 mm, 5μ) with a Methanol: Formic acid (30:70) mobile phase, a flow rate is kept as 01 mL/min, the wavelength of detection was 215 nm, and a used detector was PDA. Results: Hydrochlorothiazide (HCTZ)) and lisinopril (LIS) both had linear calibration curves (r2 = 0.9973 and 0.9983, respectively) for the ranges of concentration 4.0 to 6.0 and 10.0 to 15.0 μg/mL. The proposed technique eluted LIS in 3.97 minutes and hydrochlorothiazide in 4.53 minutes. Lisinopril had a recovery rate of 99.31 to 99.83%, whereas hydrochlorothiazide had a recovery rate of 100.75 to 101.16%. At 1.22 and 0.31 μg/mL, respectively, HCTZ as well as LIS had the lowest detectable values. It was found that the LoQs for lisinopril and hydrochlorothiazide were 0.97 and 3.75 μg/mL, respectively. Conclusion: It was found that the current RP-HPLC technique is reliable, simple to use, accurate, linear, efficient, and rapid. With a shorter analysis period, this method offers better resolution between the two compounds. Therefore, there is sufficient evidence to include the approach in regular lisinopril and hydrochlorothiazide analysis in a variety of pharmaceutical companies and academic institutions.

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